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APO-SILODOSIN DIN 02479850

Status: Approved
Holder: APOTEX INC
Molecule: SILODOSIN

Health Canada record

Active ingredient(s)SILODOSIN 4 MG
Dosage formCapsule
RouteOral
SchedulePRESCRIPTION
ClassHuman
ATCG04CA04 SILODOSIN
Original market date
Current status date13-Jan-2021
SourceHealth Canada DPD

Establishment licence of the holder

Apotex Inc — licence 100375, currently licensed, last inspection rating C (2026-04-21).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing SILODOSIN

DINProductCompanyFormStrengthStatus
02541327AG-SILODOSINANGITA PHARMA INC.CapsuleSILODOSIN 4 MGApproved
02541335AG-SILODOSINANGITA PHARMA INC.CapsuleSILODOSIN 8 MGApproved
02478528AURO-SILODOSINAURO PHARMA INCCapsuleSILODOSIN 8 MGMarketed
02478501AURO-SILODOSINAURO PHARMA INCCapsuleSILODOSIN 4 MGMarketed
02539527JAMP SILODOSINJAMP PHARMA CORPORATIONCapsuleSILODOSIN 8 MGMarketed
02539519JAMP SILODOSINJAMP PHARMA CORPORATIONCapsuleSILODOSIN 4 MGMarketed
02517779PMS-SILODOSINPHARMASCIENCE INCCapsuleSILODOSIN 4 MGMarketed
02517787PMS-SILODOSINPHARMASCIENCE INCCapsuleSILODOSIN 8 MGMarketed
02475421SANDOZ SILODOSINSANDOZ CANADA INCORPORATEDCapsuleSILODOSIN 4 MGMarketed
02475448SANDOZ SILODOSINSANDOZ CANADA INCORPORATEDCapsuleSILODOSIN 8 MGMarketed
02565986SILODOSINSANIS HEALTH INCCapsuleSILODOSIN 8 MGApproved
02565978SILODOSINSANIS HEALTH INCCapsuleSILODOSIN 4 MGApproved
02361663RAPAFLOALLERGAN INCCapsuleSILODOSIN 4 MGCancelled Post Market
02361671RAPAFLOALLERGAN INCCapsuleSILODOSIN 8 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
249902021-01-13Abbreviated New Drug Submission (ANDS)

International API supply for SILODOSIN

18 active FDA Drug Master Files.

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